November 5, 2012 - See Notice NOT-DA-13-007. Notice to Extend the Expiration Date.

April 19, 2011 - See Notice NOT-DA-11-017 This Notice is intended to clarify instructions for this FOA.

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.

January 6, 2010 -
This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the Adobe-Forms-B version of the application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the Adobe-Forms-A version of the application forms and instructions.

Program
Announcement (PA) Number: PAR-10-020

NOTICE: Applications
submitted in response to this Funding Opportunity Announcement (FOA) for
Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424
Research and Related (R&R) forms and the SF424 (R&R) Application
Guide.

APPLICATIONS MAY NOT
BE SUBMITTED IN PAPER FORMAT.

This FOA must be read
in conjunction with the application guidelines included with this announcement
in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process
is necessary before submission and applicants are highly encouraged to start
the process at least four (4) weeks prior to the grant submission date. See Section IV.

Purpose.The
purpose of this Funding Opportunity Announcement (FOA) is to invite
applications for support of drug abuse doctoral dissertation research in
epidemiology, prevention, treatment, services, and/or women and sex/gender
differences.

Funds
Available and Anticipated Number of Awards.Awards issued under this FOA are contingent upon the
availability of funds and the submission of a sufficient number of
meritorious applications.

Budget
and Project Period. Grants to support dissertation
research will provide no more than $50,000 in direct costs per year, and
are awarded for up to two years, with the possibility of extension without
additional funds for up to 12 months.

Application
Research Strategy Length: The R36 application Research Strategy
section of the PHS398 may not exceed 6 pages, including tables,
graphs, figures, diagrams, and charts. See Table of Page Limits.

Eligible
Institutions/Organizations. Any domestic public or private university or college
is eligible to apply, given that it has the staff and facilities available to
provide a suitable environment for the candidate to perform high-quality
research.

Eligible Project Directors/Principal
Investigators (PDs/PIs). The applicant for a dissertation research grant
must be enrolled in an accredited doctoral degree program in the
behavioral, biomedical, or social sciences and must propose to conduct
research in one of the areas specified in this FOA. (These awards do not
support study leading to the M.D., D.O., or D.D.S., or similar
professional degrees unless they are part of a combined degree program.)
The doctoral student must be a citizen or a non-citizen national of the United States or an individual who has been lawfully admitted for permanent residence
(i.e., in possession of an Alien Registration Receipt Card) at the time of
application. Individuals from underrepresented racial and ethnic groups as
well as individuals with disabilities are always encouraged to apply for
NIH support. A doctoral student who receives support for
dissertation research under a grant from NIDA may not hold concurrently
another federally sponsored fellowship or similar Federal award.

Number
of Applications. Only one application may be submitted per doctoral
candidate in response to this announcement.

Resubmissions.Applicants
may submit a resubmission application, but such application must include an
Introduction addressing the previous peer review critique (Summary Statement).
See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals. Recipients of the R36 award
are not eligible to submit a renewal application.

Application
Materials.SeeSection IV.1for application materials.
All applications, including resubmission, revision and renewal, submitted for due dates January 25,
2010 and beyond, must utilize the current forms and instructions.

General Information.For
general information on SF424 (R&R) Application and Electronic Submission,
see these Web sites:

The National Institute on Drug Abuse (NIDA) announces the
availability of NIH Dissertation Award grants (R36) to support drug abuse
doctoral dissertation research in epidemiology, prevention, treatment,
services, and/or women and sex/gender differences, areas in which there is a
significant need for new investigators. Grant support is designed to encourage
doctoral candidates from a variety of academic disciplines and programs to
conduct research in these areas of interest to NIDA. It is hoped that this
program will ultimately facilitate the entry of promising new investigators
into the field of drug abuse research.

Special Program Considerations for Recruiting Minority
Researchers

The primary objective of this FOA is to prepare qualified
individuals for careers that can significantly impact the Nation's drug abuse
research agenda. Within the framework of this program's commitment to
excellence in research and projected need for investigators in drug abuse
research, special attention will be given to recruiting individuals from racial
or ethnic groups underrepresented in the biomedical and behavioral sciences.
The following groups have been identified as underrepresented in biomedical and
behavioral research nationally: African Americans, Hispanic Americans, Native
Americans, Alaskan Natives, and Pacific Islanders. Use of the term
"minority" in this announcement will refer to these groups.

Research Objectives

NIDA supports more than 85 percent of the world's research on
the health aspects of drug abuse and addiction. Research supported by NIDA
encompasses basic, behavioral, and applied sciences related to the underlying
mechanisms and health effects of drugs of abuse. This FOA is to provide students
with grant-in-aid support to perform drug abuse dissertation research on a
topic related to the study of epidemiology, prevention, treatment, services, or
women and sex/gender differences, and thereby increase the pool of highly
talented drug abuse scientists who conduct research in these areas.

The descriptions below are examples of the research foci of
this grant program and are provided to guide potential applicants to determine
whether a given scientific topic may be appropriate for this initiative. These
descriptions are not intended to be comprehensive. In addition, given the
complexity of drug abuse research, it is permitted to conduct the proposed
dissertation research in conjunction with an ongoing research study or to use
extant data. Research studies focused on HIV/AIDS and Health Disparities are
encouraged.

Studies of the underlying physiological and psychosocial
mechanisms associated with the transition from lower to higher levels of drug
involvement and from higher levels of drug involvement to dependence and
addiction.

Development and improvement of techniques for studying drug
abuse, including enhancements in measurement, development of improved sampling
procedures, and refinement of analytic methods.

Development of innovative approaches to identify both
physical (ecological) and social environmental/contextual characteristics of
local communities that influence drug use, emerging drug use patterns, and
adverse drug-related outcomes.

Delineation of the underlying dynamic causal mechanisms
associated with drug use patterns and adverse drug-related outcomes by
integrating individual and community level factors.

Studies of emerging trends (e.g., club drugs), including
studies that relate these trends to influences such as changes in social
attitudes, new drugs of abuse, new patterns of social interaction, new
technologies, new drug trafficking patterns, and similar macro-level changes.

Research on drug use and drug-related consequences among
ethnic/racial minority groups and other underserved populations. This includes
studies that uncover the basis for racial/ethnic disparities in drug use and
social, behavioral, and health outcomes related to drug use.

Research to assess the impact of mental health interventions
in childhood on subsequent drug abuse.

Studies to assess the nature, scope, and consequences of
drug-related crime including violent and nonviolent crime.

Research to assess the impact of drug use on adverse
behavioral, social, and health consequences (e.g., violence, educational
attainment, HIV) as well as the role of adverse consequences on further drug
involvement.

Prevention:

Studies that use findings on cognitive strategies and
functioning to improve or develop targeted drug abuse or drug-related HIV
prevention messages and approaches.

Studies on the efficacy of drug abuse prevention program and
strategies that are largely untested but widely used such as: case management,
mentoring, job training, and challenge activities.

Studies to develop and test the efficacy of interventions for
specific contexts such as primary care settings, college and/or personnel
orientation programs, workplaces, faith-based settings, and community
recreational settings.

The development and assessment of physiological and
biochemical measures that may elucidate cognitive and affective factors
associated with individual responsiveness to particular prevention
interventions.

The development of methodological approaches to solve common
problems faced in the analysis of complex multi-wave datasets.

Behavioral and integrative treatment research at NIDA is
guided by a stage model of therapy development. For a detailed description of
this model, as well as NIDA's therapy development and testing priorities,
please see the Behavioral Therapies Development Program Announcement at: (http://grants.nih.gov/grants/guide/pa-files/PA-10-011.html)
Examples of behavioral treatment research appropriate for this announcement
include, but are not limited to the following:

Utilizing relevant research from the animal model literature
(e.g., avoidance and impulsivity paradigms) to develop or improve
treatments/interventions.

Utilizing relevant research from the developmental (e.g.,
basic research on familial and peer influences during adolescence) or social
psychology (e.g., basic research on stereotyping) literatures to improve
treatments.

Adapting/modifying evidence-based treatments for use in
non-traditional and community settings, into community-friendly formats (e.g.,
individual to group, briefer formats, less intensive delivery,
computer-assisted delivery, etc.), and evaluating their resulting potency

Developing and assessing treatment provider training
procedures for evidence-based treatments (e.g., computerizing training
procedures; this can include initial training as well as supervision
requirements).

Research involving secondary analyses of existing behavioral
treatment research data sets to identify predictors, moderators, or mediators
of treatment outcome, mechanisms of action of treatment, or secondary effects
of treatment on participants in various contexts (e.g., peer group, school,
work, family) or on participants? family members (e.g., children).

Research on instrument development and/or psychometric
analysis of tools for the clinical assessment of drug abuse, treatment efficacy,
treatment fidelity, and HIV risk, or for constructs believed to be related to
mechanisms of action of behavioral treatment efficacy.

Research to develop and test a therapy module to be added to
an existing therapy to address targeted issues (e.g., adding an HIV risk
reduction module to a family therapy for drug-abusing adolescents).

Research to integrate innovative health technologies into new
or existing behavioral and integrative treatments.

Research testing a principle of behavior change among drug-abusers
in treatment (e.g., by adding more frequent or multi-method assessments to an
existing study in order to track behavior change over time).

Services:

Studies to assess the impact of financing and organizational
and managerial factors on access to and use, quality, efficiency, costs, and
outcomes of prevention and treatment services.

Research to measure the effectiveness, cost-effectiveness,
and cost-benefits of drug abuse prevention and treatment services.

Drug abuse service delivery systems and models, such as
continuity of care, development of therapeutic rapport, service linkages and
integration models.

Drug abuse treatment and prevention services for HIV
seropositive patients and for those at risk of HIV infection and other diseases
that are a consequence of drug abuse.

Studies focusing on management strategies (e.g., work team
models, quality management) and business practices aimed at improving the
quality, effectiveness, and efficiency of drug abuse treatment and prevention
services.

Research focusing on the development or improvement of
research methods---including but not limited to study design, measurement, data
collection, and analytic procedures---for studying the societal impact of drug
abuse and/or the delivery, quality, outcomes, and economics of drug abuse prevention
or treatment services.

Women and Sex/Gender
Differences:

Through this dissertation award program, NIDA seeks to foster
research on females and sex/gender differences in all areas of drug abuse
research. From basic cellular and genetics research to epidemiology,
prevention, treatment, and services research, investigators are encouraged to
explore the possible importance of sex/gender differences in their chosen area
of study and to explore drug abuse issues specific to females. Examples of research
areas include, but are not limited to the following:

Sex/Gender differences in the basic behavioral, biological,
and genetic mechanisms underlying drug abuse and addiction; and laboratory
(both human and animal), clinical, and epidemiological studies of sex/gender
differences in the determinants of initiation, progression, maintenance of drug
use and addiction, and responsiveness to treatment.

Laboratory (both human and animal), field, and clinical
research aimed at: (1) identifying sex/gender differences in the consequences
of drug use, abuse, and addiction following acute use, chronic use, as well as
residual effects following prolonged abstinence, and (2) examining drug-related
consequences that are unique to females.

The application of sex/gender-specific theories and empirical
research on the origins, pathways, and risk and protective factors related to
drug use, progression/transition, and maintenance, to the design, development,
and testing of gender-sensitive prevention and treatment strategies and
interventions to determine effectiveness and efficacy.

The development and testing of theoretically-based drug
treatment approaches (including behavioral treatment and pharmacotherapies)
that address sex/gender-specific issues and the examination of sex/gender-specific
issues related to the effective and efficient delivery of drug abuse treatment
services.

The development and evaluation of sex/gender-specific
interventions directed at preventing HIV infection and treating HIV/AIDS among
drug using populations.

Questions on the relevance of a particular research topic to
NIDA's scientific mission and other questions about this FOA should be
addressed to the program contact listed under INQUIRIES. Potential applicants
are strongly encouraged to discuss their application with the appropriate
program contact.

This
FOA will use theNational Institutes
of Health (NIH) Dissertation Award (R36) mechanism. The predoctoral student is
the Project Director/Principal Investigator (PD/PI) of the application. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project under the supervision, and with the approval, of
a university-approved and appointed doctoral committee. The student-PD/PI must
have an appointment at the applicant institution (e.g., research assistant).

These
awards support research activities related to preparation of a dissertation and
do not support study leading to the M.D., D.O., or D.D.S., or similar
professional degrees unless they are part of a combined degree program (see:
Individual Pre-doctoral National Research Award for M.D./Ph.D. Fellowships -
PA-99-089, which may be obtained from: http://grants.nih.gov/grants/guide/pa-files/PA-09-207.html. For additional information
on training opportunities, please visit NIDA?s Research Training Opportunities
Website (http://www.nida.nih.gov/ResearchTraining/Traininghome.html).

Dissertation
awards are not renewable nor may they be transferred to another PD/PI.
Applicants may submit one resubmission in response to this FOA.

2.
Funds Available

Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. However, the total project period for an application submitted in
response to this FOA may not exceed two years and may be extended without
additional funds for up to 12 months. Grants to support dissertation research
will provide no more than $50,000 in direct costs per year.

Allowable
Costs: Expenses usually allowed under PHS research grants will be covered by
the NIDA dissertation research grant, but may not exceed $50,000 per year in
direct costs. An application that requests more than $50,000 per year in direct
costs will not be reviewed. Allowable costs include the applicant salary (not
to exceed NIH's current salary for predoctoral fellows for 12 months full-time
effort). In developing the non-modular budget, applicants may also include
costs for research assistants' salaries, and direct research project expenses,
such as data processing, payments to subjects, supplies, consultants, and
dissertation costs (e.g., printing and binding of the dissertation). No
tuition, alteration/renovations, contracting costs, faculty salary, or space
rental are allowed on dissertation research grants. Indirect costs are limited
to eight percent of requested direct costs, less equipment.

Any
level of effort by the applicant that is less than full time (40 hours per
week) must be fully justified, and the applicant's salary must be prorated
accordingly.

Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation, see NOT-OD-05-004.

Number
of Applications. A doctoral candidate may submit only one application
in response to this announcement.

Resubmissions. Applicants may
submit a resubmission application, but such application must include an
Introduction addressing the previous peer review critique (Summary
Statement). Beginning with applications
intended for the January 25, 2009 official submission due date, all original
new applications (i.e., never submitted) are permitted only a single amendment
(A1). See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Renewals.Recipients of the R36 award are not
eligible to submit a renewal application.

Section IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) Application
Guide for completing the SF424 (R&R) forms for this FOA, use the ?Apply for
Grant Electronically? button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the
steps of the registration process could take four weeks or more. Therefore,
applicants should immediately check with their business official to determine
whether their organization/institution is already registered with both Grants.gov and the Commons.
All registrations must be complete by the submission deadline for the
application to be considered ?on-time? (see 3.C.1 for more information about
on-time submission).

A one-time registration
is required for institutions/organizations at both:

The individual(s) designated as
PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned
the PI role in the eRA Commons prior to the submission of the application.

Each PD/PI must
hold a PD/PI account in the Commons. Applicants should not share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have both a
PD/PI role and an Internet Assisted Review (IAR) role, both roles should exist
under one Commons account.

When multiple PDs/PIs are
proposed, all PDs/PIs at the applicant organization must be affiliated with
that organization. PDs/PIs located at another institution need not be
affiliated with the applicant organization, but must be affiliated with their
own organization to be able to access the Commons.

This registration/affiliation must
be done by the AOR/SO or his/her designee who is already registered in the Commons.

Both the PD(s)/PI(s)
and AOR/SO need separate accounts in the NIH eRA Commons since both are
authorized to view the application image.

Note: The registration
process is not sequential. Applicants should begin the registration processes
for both Grants.gov and eRA Commons as soon as their organization has obtained
a DUNS number. Only one DUNS number is required and the same DUNS number must
be referenced when completing Grants.gov registration, eRA Commons registration
and the SF424 (R&R) forms.

1.
Request Application Information

Applicants must
download the SF424 (R&R) application forms and the SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.

Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are required by NIH (e.g., the ?Credential? log-in
field of the ?Research & Related Senior/Key Person Profile? component must
contain the PD/PI?s assigned eRA Commons User ID). Agency-specific
instructions for such fields are clearly identified in the Application Guide.
For additional information, see ?Frequently Asked Questions ? Application
Guide, Electronic Submission of Grant Applications.?

The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable
components, required and optional. A completed application in response to this
FOA includes the data in the following components:

When multiple
institutions are involved, one institution must be designated as the prime
institution and funding for the other institution(s) must be requested via a
subcontract to be administered by the prime institution. When submitting a
detailed budget, the prime institution should submit its budget using the
Research & Related Budget component. All other institutions should
have their individual budgets attached separately to the Research & Related
Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R)
Application Guide for further instruction regarding the use of the subaward
budget form.

When submitting a
modular budget, the prime institution completes the PHS398 Modular Budget
component only. Information concerning the consortium/subcontract budget
is provided in the budget justification. Separate budgets for each
consortium/subcontract grantee are not required when using the Modular budget
format. See Section 5.4 of the Application Guide for further instruction
regarding the use of the PHS398 Modular Budget component.

Applications may be submitted on or after the opening date and must be
successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application due date(s). (See Section
IV.3.A. for all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must
meet the following criteria to be considered ?on-time?:

All
registrations must be complete prior to the submission deadline

The
application must receive a Grants.gov tracking number and timestamp (or eRA
help desk ticket confirming a system issue preventing submission) by 5:00 p.m.
local time on the submission deadline date.

Any
system identified errors/warnings must be corrected and the submission process
completed within the ?error correction window.?

Submission to Grants.gov is not the last step ?
applicants must follow their application through to the eRA Commons to check
for errors and warnings and view their assembled application!

3.C.2 Two Day
Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an application package has been
successfully submitted through Grants.gov,NIH provides
applicants a two day error correction window to correct any eRA
identified errors or warnings before a final assembled application is created
in the eRA Commons. The standard error correction window is two (2) business
days, beginning the day after the submission deadline and excluding weekends and
standard federal holidays. All errors must be corrected to successfully
complete the submission process. Warnings will not prevent the application
from completing the submission process.

Please note that the following
caveats apply:

Initial
application submission must be ?on-time.?

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that includes
additional changes.

Proof of ?on-time? submission (e.g., Grants.gov timestamp and
tracking number) and description of all changes made within the window must be
documented in the PHS 398 Cover Letter component of the application.

3.C.3 Viewing
an Application in the eRA Commons

Once any eRA identified errors have been
addressed and the assembled application has been created in the eRA Commons, the PD/PI and
the Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday ? Friday, excluding Federal holidays) to view the assembled application before it
automatically moves forward to NIH for further processing.

If everything is
acceptable, no further action is necessary. The application
will automatically move forward to the Division of Receipt and Referral in
the Center for Scientific Review for processing after two weekdays,
excluding Federal holidays.

Prior to the submission
deadline, the AOR/SO can ?Reject? the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process. ,The AOR/SO will have the option to ?Reject? the application and
submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to
ensure that the issues are addressed and corrected. Once rejected,
applicants should follow the instructions for correcting errors in Section
2.12, including the requirement for cover letters on late applications.The ?Reject?
feature should also be used if you determine that warnings are applicable
to your application and need to be addressed now. Remember, warnings do
not stop further application processing. If an application submission
results in warnings (but no errors), it will automatically move forward
after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.

If
the two-day window falls after the submission deadline, the AOR/SO will have
the option to ?Reject? the application if, due to an eRA Commons or Grants.gov
system issue, the application does not correctly reflect the submitted
application package (e.g., some part of the application was lost or didn?t transfer
correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and
determine the best course of action. NIH will not penalize the applicant for an
eRA Commons or Grants.gov system issue.

If
the AOR/SO chooses to ?Reject? the image after the submission deadline for a
reason other than an eRA Commons or Grants.gov system failure, a
changed/corrected application still can be submitted, but it will be subject to
the NIH
late policy guidelines and may not be accepted. The reason for this delay should be
explained in the cover letter attachment.

Both
the AOR/SO and PD/PI will receive e-mail notifications when the application is
rejected or the application automatically moves forward in the process after
two weekdays.

Upon
receipt, applications will be evaluated for completeness by the Center for Scientific Review,
NIH.
Incomplete applications will not be reviewed.

There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
the application status in the Commons.

The NIH will not
accept any application in response to this FOA that is essentially the same as
one currently pending initial merit review unless the applicant withdraws the
pending application. The NIH will not accept any application that is
essentially the same as one already reviewed. However, the NIH will accept a
resubmission application, but such application must include an Introduction (1
page maximum) addressing the critique from the previous review.

All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award
costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such
costs: 1) are necessary to conduct the project, and 2) would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new award.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Letter of Certification: A letter from the faculty
committee or university official directly responsible for supervising the
development and progress of the dissertation research must be submitted with
the application. The letter must: (a) fully identify the members of the
dissertation committee and certify their approval of the dissertation proposal;
(b) certify that all requirements for the doctoral degree, except the
dissertation and, if necessary, the clinical internship, are completed or will
be completed by the time the grant award starts; (c) note that the university
official or faculty committee expects the doctoral candidate to proceed with
the approved project proposal with or without NIDA support; and (d) briefly
describe the facilities and resources for the project and certify that they are
adequate to conduct the proposed research. As only 1 .pdf file is allowed for
the Letter of Support item in the PHS Research Strategy, combine this letter
with Letters of Support (below) into one file.

Letters of Support: Information on the student's academic
standing as well as a commitment from the school to implement the study as
proposed must be included in the application. The student's advisor must submit
with the grant application a letter of recommendation in support of the
candidate and the proposed research dissertation. This should be placed in the Letters of Support attachment.

Official Transcript: A copy of an official transcript of
the applicant's graduate school record should be included with the application.
The transcript should be placed in the Appendix.

Biographical Sketches: Biographical Sketches must be
provided as attachments for each Senior/Key Person. The mentor is considered a
key person on the proposed project and his/her profile must be included under
the Senior/Key Person Profile(s) Component. For the ?doctoral candidate,? the
attached Biographical Sketch must also contain a scientific autobiography that
states his/her career goals, including reference to their interest in the
specific areas of research designated in this FOA and a description of their
intended career trajectory. This information will be used by NIDA program staff
to determine how the proposed study addresses program priorities.

Project
Description: The applicant must provide a narrative project description (not to
exceed 6 pages)
that contains a detailed scientific and technical discussion of the following
specific points:

a. A description of the research project and what it is
intended to be accomplished.

b. A summary of related published research that addresses
the identified problem(s).

c. The questions to be answered or the hypotheses to be
tested by the project.

d. The methodological procedures to be followed and,
whenever applicable, information on such matters as sampling procedures,
including the size and composition of the population to be studied and the size
and composition of the sample and control groups, as well as a description of
the types and sources of data to be gathered, methodological problems to be
encountered, specific statistical analyses to be used, and steps that will be
taken to protect human subjects.

e. The management of the project
including a schedule of the main steps of the proposed investigation.

The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For
additional information, see ?Frequently Asked Questions ? Application Guide, Electronic Submission of Grant Applications.?

Research Strategy Page
Limitations

The
R36 application Research Strategy section of the PHS398 may not exceed 6 pages,
including tables, graphs, figures, diagrams, and charts. See Table of Page
Limits.

All
application instructions outlined in the SF424 (R&R) Application Guide are
to be followed, incorporating "Just-in-Time" information concepts.

Do
not use the Appendix to circumvent the page limitations.. An application that
does not comply with the required page limitations may be delayed in the review
process.

Resource Sharing Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value and further the
advancement of the research. When resources have been developed with NIH funds
and the associated research findings published or provided to NIH, it is
important that they be made readily available for research purposes to
qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not
Applicable

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of model
organisms is anticipated are expectedto include a description of
a specific plan for sharing and distributing unique model organisms and related
resources, or state appropriate reasons why such sharing is restricted or not
possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless
of the amount requested, applicants seeking funding for a genome-wide
association study are expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A
genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (e.g., blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy for Sharing
of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies
(go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Section V. Application Review Information

1.
Criteria

Only
the review criteria described below will be considered in the review process.

2. Review and
Selection Process

Review
Process

Applications
submitted for this funding opportunity will be assigned on the basis of
established PHS referral guidelines to the ICs for funding consideration.

Applications
that are complete will be evaluated for scientific and technical merit by (an)
appropriate scientific review group(s) in accordance
with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As
part of the scientific peer review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned an impact/priority
score;

Receive
a written critique; and

Receive
a second level of review by the appropriate national
advisory council or board.

The mission
of the NIH is to support science in pursuit of knowledge about the biology and
behavior of living systems and to apply that knowledge to extend healthy life
and reduce the burdens of illness and disability. As part of this
mission, applications submitted to the NIH for grants or cooperative agreements
to support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system.

Overall
Impact. Reviewers will provide an overall impact/priority
score to reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in consideration
of the following five core review criteria, and additional review criteria (as
applicable for the project proposed).

Core Review
Criteria. Reviewers will consider each of the five
review criteria below in the determination of scientific and technical merit,
and give a separate score for each. An application does not need to be
strong in all categories to be judged likely to have major scientific
impact. For example, a project that by its nature is not innovative may
be essential to advance a field.

Significance. Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change
the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)/Mentor(s). Is the work proposed appropriate to the experience level of the
applicant? Does the applicant show promise as a research investigator in areas
relevant to the proposal? Is the proposed research project consistent with the
long-term research interests of the applicant? Are the faculty
advisor/dissertation chair and other doctoral committee members appropriately
qualified to provide guidance as needed? Have the faculty advisor/dissertation
chair and any other participating members of the committee indicated that they
will provide sufficient time to allow completion of the dissertation? Will the
faculty advisor/dissertation chair provide the necessary supervision and
mentoring to the applicant?

Innovation. Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions?
Are the concepts, approaches or methodologies, instrumentation, or
interventions novel to one field of research or novel in a broad sense?
Is a refinement, improvement, or new application of theoretical concepts,
approaches or methodologies, instrumentation, or interventions proposed?

Approach. Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the
project? Are potential problems, alternative strategies, and benchmarks
for success presented? If the project is in the early stages of
development, will the strategy establish feasibility and will particularly
risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment. Will the scientific environment in which the work
will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the applicants
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional
Review Criteria

As applicable
for the project proposed, reviewers will consider the following additional
items in the determination of scientific and technical merit, but will not give
separate scores for these items.

Protections
for Human Subjects. For research that
involves human subjects but does not involve one of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate the
justification for involvement of human subjects and the proposed protections
from research risk relating to their participation according to the following
five review criteria: 1) risk to subjects, 2) adequacy of protection against
risks, 3) potential benefits to the subjects and others, 4) importance of the
knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research
that involves human subjects and meets the criteria for one or more of
the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials.

Inclusion
of Women, Minorities, and Children. When
the proposed project involves clinical research, the committee will evaluate
the proposed plans for inclusion of minorities and members of both genders, as
well as the inclusion of children.

Vertebrate
Animals. The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following five points: 1) proposed use of the animals, and
species, strains, ages, sex, and numbers to be used; 2) justifications for the use
of animals and for the appropriateness of the species and numbers proposed; 3)
adequacy of veterinary care; 4) procedures for limiting discomfort, distress,
pain and injury to that which is unavoidable in the conduct of scientifically
sound research including the use of analgesic, anesthetic, and tranquilizing
drugs and/or comfortable restraining devices; and 5) methods of euthanasia and
reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

Resubmission
Applications. When reviewing a Resubmission
application (formerly called an amended application), the committee will
evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Biohazards. Reviewers will assess whether materials or
procedures proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Additional
Review Considerations

As applicable
for the project proposed, reviewers will address each of the following items,
but will not give scores for these items and should not consider them in
providing an overall impact/priority score.

Budget
and Period Support. Reviewers will
consider whether the budget and the requested period of support are fully
justified and reasonable in relation to the proposed research.

A formal notification
in the form of a Notice of Award (NoA) will be provided to the applicant
organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.

Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5., ?Funding
Restrictions.?

A final progress report, invention statement,
and Financial Status Report are required when an award is relinquished when a
recipient changes institutions or when an award is terminated.

Section
VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research (program), peer review, and financial or
grants management issues:

Human Subjects
Protection:Federal regulations (45 CFR 46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against these
risks, the potential benefits of the research to the subjects and others, and
the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (?NIH Policy for
Data and Safety Monitoring,? NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the repository
is not possible. Data repository management (submission and access) is governed
by the Policy for Sharing of Data Obtained in NIH Supported or Conducted
Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH
recognizes the rights of grantees and contractors to elect and retain title to
subject inventions developed with Federal funding pursuant to the Bayh-Dole Act
(see the NIH Grants Policy Statement. Beginning October 1, 2004,
all investigators submitting an NIH application or contract proposal are
expected to include in the application/proposal a description of a specific
plan for sharing and distributing unique model organism research resources
generated using NIH funding or state why such sharing is restricted or not
possible. This will permit other researchers to benefit from the resources
developed with public funding. The inclusion of a model organism sharing plan
is not subject to a cost threshold in any year and is expected to be included
in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to
place data collected under this funding opportunity in a public archive, which
can provide protections for the data and manage the distribution for an
indefinite period of time. If so, the application should include a description
of the archiving plan in the study design and include information about this in
the budget justification section of the application. In addition, applicants
should think about how to structure informed consent statements and other human
subjects procedures given the potential for wider use of data collected under
this award.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research? (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the
updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy
incorporates: the use of an NIH definition of clinical research; updated racial
and ethnic categories in compliance with the new OMB standards; clarification
of language governing NIH-defined Phase III clinical trials consistent with the
SF424 (R&R) application; and updated roles and responsibilities of NIH
staff and the extramural community. The policy continues to require for all
NIH-defined Phase III clinical trials that: a) all applications or proposals
and/or protocols must provide a description of plans to conduct analyses, as
appropriate, to address differences by sex/gender and/or racial/ethnic groups,
including subgroups if applicable; and b) investigators must report annual
accrual and progress in conducting analyses, as appropriate, by sex/gender
and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human Subject
Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy,investigators
funded by the NIH must submit or have submitted for them to the
National Library of Medicine?s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no
later than 12 months after the official date of publication. The
NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable
Health Information:The Department
of Health and Human Services (HHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the HHS
Office for Civil Rights (OCR).

Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs
in NIH Grant Applications or Appendices:
All applications and proposals
for NIH funding must be self-contained within specified page limitations. For
publications listed in the appendix and/or Progress report, Internet addresses
(URLs) or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference
in either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This program is described in the Catalog
of Federal Domestic Assistance athttp://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject
to the terms and conditions, cost principles, and other considerations described
in the NIH Grants Policy
Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are provided
to children. This is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

Loan
Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.